MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-530PA; TRANSMITTER

Model Number ZM-530PA

Device Problems Overheating of Device (1437); Temperature Problem (3022)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/08/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the telemetry transmitter was getting hot and depleting new batteries within minutes.They tried replacing the back cover of the battery and the middle cover but problem is still occurring.Not in patient use.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 when additional information becomes available.Additional device information: concomitant medical device field contains not applicable (na), as the device was not in patient use and not being used in conjunction with other devices.

Event Description

The customer reported that the telemetry transmitter was getting hot and depleting new batteries within minutes.They tried replacing the back cover of the battery and the middle cover but problem is still occurring.Not in patient use.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 when additional information becomes available.

Manufacturer Narrative

Details of complaint: the customer reported that the telemetry transmitter was getting hot and depleting new batteries within minutes.They tried replacing the back battery cover and middle enclosure, but the issue persisted.The device was not in patient use.Service requested / performed: an evaluation was performed by nkc ((b)(4)) for the zm-52/53 series regarding overheating of the device case when the battery short-circuit occurs at the battery spring.The state of the temperature increasing was viewed by the thermography.The conclusion of this evaluation was that the temperature battery increased right after the short-circuit.The temperature of the battery terminal partly increased, and the terminal protector was melted.The battery temperature terminal partly increased to 78.6 degrees c in about 10 seconds after the incorrect insertion and the temperature decreased to about 40 degrees c after 30 seconds (about 40 seconds after the incorrect insertion) and the heat spread to the whole of the battery.This could be dissipated by the battery case, pouch, and gown which will act as thermal insulators.The operator's manual instructs the user to avoid contact of the transmitter to bare skin and to check if the transmitter is hot after inserting the batteries.Investigation summary: the overheating of the battery compartment could be caused due to a number of reasons, such as: the battery is inserted in a wrong polarity causing overcurrent , battery is inserted forcibly, causing fire due to short-circuit of +/- terminals , short-circuit between the +/- battery terminals, user does not handle nimh secondary battery and a battery charger properly, causing a short-circuit of the +/- terminals.Investigation determined that the reported issue could have been caused due to incorrect usage and maintenance of the nk device.

Event Description

The customer reported that the telemetry transmitter was getting hot and depleting new batteries within minutes.They tried replacing the back battery cover and middle enclosure, but the issue persisted.The device was not in patient use.

• Brand Name: ZM-530PA
• Type of Device: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 116-8 560; JA 116-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; attn: shama mooman; 1-1 tajino; tomioka city, gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 10360566
• MDR Text Key: 201566242
• Report Number: 8030229-2020-00420
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921115091
• UDI-Public: 4931921115091
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043517
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/03/2020,09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZM-530PA
• Device Catalogue Number: ZM-530PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/03/2020
• Distributor Facility Aware Date: 07/08/2020
• Device Age: 86 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/03/2020
• Date Manufacturer Received: 08/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1